Regulatory Updates
FDA, EMA, TGA and global regulatory developments
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves Multiple Submissions for Indomethacin NDA 018858, Products Discontinued
The FDA has approved a series of manufacturing and labeling submissions for Indomethacin (NDA 018858). Both listed capsule products (25 mg and 50 mg) are marked discontinued.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves ANDA090353 for Senores Pharms Topiramate Tablets (Discontinued)
Senores Pharms' ANDA090353 for oral Topiramate tablets (25‑200 mg) received FDA approval; all listed products are marked discontinued.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves ANDA090007 for Generic Gabapentin Capsules
FDA has approved ANDA090007 for generic gabapentin oral capsules in 100 mg, 300 mg, and 400 mg strengths, manufactured by Time Cap Laboratories, Bi‑Coastal Pharma, and Marksans Pharma.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Discontinues Wellcovorin Injection (ANDA089465)
The FDA records show that the injectable product Wellcovorin, containing Leucovorin Calcium (50 mg per vial), has been marked as discontinued under ANDA089465.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves Methyclothiazide Tablet (ANDA 088750)
The FDA has approved ANDA 088750 for a 2.5 mg oral tablet of methyclothiazide submitted by Watson Labs; the product is listed as discontinued.
Regulatory Updates
Sep 16, 2026•1 min read
Korea to Merge Three Drug Safety Agencies into New Korean Pharmaceutical Safety Agency
The government plans to consolidate the Korean Rare Essential Medicines Center, the Pharmaceutical Safety Management Agency and the Vaccine Safety Technology Support Center under a new Korean Pharmaceutical Safety Agency.
Regulatory Updates
Sep 16, 2026•1 min read
MFDS Identifies GCP Gaps in Dayvigofilm Coating Tablet (Rembolexant) Approval Process
The Korean MFDS flagged protocol adherence, monitoring and record‑keeping issues in the clinical trial for Dayvigofilm coating tablet, though no serious violations were found.
Regulatory Updates
Sep 16, 2026•1 min read
Experts Call for New Evaluation System for Innovative Cancer Drugs in Korea
At a forum on sustainable healthcare, Professor Ahn Hee‑kyung highlighted bottlenecks in Korean patients’ access to innovative anticancer drugs and urged a valuation framework that includes clinical and socioeconomic benefits.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Discontinues Hydroxyzine Hydrochloride Injection (ANDA 089107)
The FDA has listed Hydroxyzine Hydrochloride injectable (product 001) from sponsor PharmaFair as discontinued under ANDA 089107.
Regulatory Updates
Sep 16, 2026•1 min read
PHARMAFAIR's Fluocinolone Acetone Topical Solution Discontinued – ANDA088449
FDA records show PHARMAFAIR's topical fluocinolone acetone 0.01% solution (product 001) is marked as discontinued under ANDA088449.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves ANDA 088119 for Isoniazid 300 mg Tablet
The FDA approved application ANDA088119 for an oral Isoniazid 300 mg tablet marketed by Duramed Pharms Barr. The product is listed as discontinued and includes a detailed submission history.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Records Show Discontinued BENEMID (Probenecid) Tablet with Multiple Priority Submissions
The FDA database lists BENEMID, an oral 500 mg probenecid tablet, as discontinued but not for safety or effectiveness reasons, and documents numerous priority supplemental submissions spanning 1976‑1994.